Abstract

Institutions are constructed in institutional environments, which partially structure the process of institutional design, and ultimately help determine the shape of these institutions. The recently created European Medicinal Evaluation Agency (EMEA) in the European Union is an excellent example of this process, and as such, will be the subject of this study. Of specific empirical interest is how European-level pharmaceutical policy evolved from the first European legislation on medicinal drugs in the 1960s to the formation of a European pharmaceutical agency in the 1990s ... the choices that led to the EMEA will be analyzed as one of many potential rational solutions to the problems encountered in the realm of pharmaceutical policy. This agency was a solution that was only partially constructed through intentional behavior, since it was equally a product of the historical evolution and institutional context of the EU. This paper will relate the story of the EMEA in a manner that demonstrates not only how member state and EU institutions interacted to create the agency, but also how rational decisions were constrained by the evolutionary processes of European integration.